اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BETAPACE AF از شرکت COVIS
New Drug Application (NDA): 021151
Company: COVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/22/2000 | ORIG-1 | Approval |
Type 6 – New Indication (no longer used) |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/17/2011 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s010ltr.pdf |
||
| 02/03/2011 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021151s009ltr.pdf |
||
| 04/02/2003 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs005ltr.pdf |
|
| 03/14/2003 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21151scs004ltr.pdf |
|
| 10/01/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/22/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/17/2011 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s010lbl.pdf | |
| 02/03/2011 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021151s009lbl.pdf | |
| 02/22/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21151lbl.pdf |
BETAPACE AF
TABLET;ORAL; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | COVIS |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 076214 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 207428 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 207429 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 077070 | EPIC PHARMA INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |
TABLET;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | COVIS |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 076214 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 207428 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 207429 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 077070 | EPIC PHARMA INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |
TABLET;ORAL; 160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | Yes | AB | 019865 | COVIS |
| BETAPACE AF | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | Yes | AB | 021151 | COVIS |
| SORINE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075500 | UPSHER SMITH LABS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 076140 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 076214 | APOTEX |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 207428 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 207429 | BEXIMCO PHARMS USA |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 077070 | EPIC PHARMA INC |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075563 | OXFORD PHARMS |
| SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET;ORAL | Prescription | No | AB | 075429 | TEVA |
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